Anchor and pull mitral valve device and method

ABSTRACT

A device, system, and method effects mitral valve annulus geometry of a heart. The device includes a first anchor configured to be positioned within and fixed to the coronary sinus of the heart adjacent the mitral valve annulus within the heart. A cable is fixed to the first anchor and extends proximately therefrom and slidingly through a second anchor which is positioned and fixed in the heart proximal to the first anchor. A lock locks the cable to the second anchor when tension is applied to the cable for effecting the mitral valve annulus geometry.

FIELD OF THE INVENTION

[0001] The present invention generally relates to a device and methodfor treating dilated cardiomyopathy of a heart. The present inventionmore particularly relates to a device and method for reshaping themitral valve annulus.

BACKGROUND OF THE INVENTION

[0002] The human heart generally includes four valves. Of these valves,a most critical one is known as the mitral valve. The mitral valve islocated in the left atrial ventricular opening between the left atriumand left ventricle. The mitral valve is intended to preventregurgitation of blood from the left ventricle into the left atrium whenthe left ventricle contracts. In preventing blood regurgitation themitral valve must be able to withstand considerable back pressure as theleft ventricle contracts.

[0003] The valve cusps of the mitral valve are anchored to muscular wallof the heart by delicate but strong fibrous cords in order to supportthe cusps during left ventricular contraction. In a healthy mitralvalve, the geometry of the mitral valve ensures that the cusps overlieeach other to preclude regurgitation of the blood during leftventricular contraction.

[0004] The normal functioning of the mitral valve in preventingregurgitation can be impaired by dilated cardiomyopathy caused bydisease or certain natural defects. For example, certain diseases maycause dilation of the mitral valve annulus. This can result indeformation of the mitral valve geometry to cause ineffective closure ofthe mitral valve during left ventricular contraction. Such ineffectiveclosure results in leakage through the mitral valve and regurgitation.Diseases such as bacterial inflammations of the heart or heart failurecan cause the aforementioned distortion or dilation of the mitral valveannulus. Needless to say, mitral valve regurgitation must not gouncorrected.

[0005] One method of repairing a mitral valve having impaired functionis to completely replace the valve. This method has been found to beparticularly suitable for replacing a mitral valve when one of the cuspshas been severely damaged or deformed. While the replacement of theentire valve eliminates the immediate problem associated with a dilatedmitral valve annulus, presently available prosthetic heart valves do notpossess the same durability as natural heart valves.

[0006] Various other surgical procedures have been developed to correctthe deformation of the mitral valve annulus and thus retain the intactnatural heart valve function. These surgical techniques involverepairing the shape of the dilated or deformed valve annulus. Suchtechniques, generally known as annuloplasty, require surgicallyrestricting the valve annulus to minimize dilation. Here, a prosthesisis typically sutured about the base of the valve leaflets to reshape thevalve annulus and restrict the movement of the valve annulus during theopening and closing of the mitral valve.

[0007] Many different types of prostheses have been developed for use insuch surgery. In general, prostheses are annular or partially annularshaped members which fit about the base of the valve annulus. Theannular or partially annular shaped members may be formed from a rigidmaterial, such as a metal, or from a flexible material.

[0008] While the prior art methods mentioned above have been able toachieve some success in treating mitral regurgitation, they have notbeen without problems and potential adverse consequences. For example,these procedures require open heart surgery. Such procedures areexpensive, are extremely invasive requiring considerable recovery time,and pose the concomitant mortality risks associated with suchprocedures. Moreover, such open heart procedures are particularlystressful on patients with a comprised cardiac condition. Given thesefactors, such procedures are often reserved as a last resort and henceare employed late in the mitral regurgitation progression. Further, theeffectiveness of such procedures is difficult to assess during theprocedure and may not be known until a much later time. Hence, theability to make adjustments to or changes in the prostheses to obtainoptimum effectiveness is extremely limited. Later corrections, if madeat all, require still another open heart surgery.

[0009] An improved therapy to treat mitral regurgitation withoutresorting to open heart surgery has recently been proposed. This isrendered possible by the realization that the coronary sinus of a heartis near to and at least partially encircles the mitral valve annulus andthen extends into a venous system including the great cardiac vein. Asused herein, the term “coronary sinus” is meant to refer to not only thecoronary sinus itself but in addition, the venous system associated withthe coronary sinus including the great cardiac vein. The therapycontemplates the use of a device introduced into the coronary sinus toreshape and advantageously effect the geometry of the mitral valveannulus.

[0010] The device includes a resilient member having a cross sectionaldimension for being received within the coronary sinus of the heart anda longitudinal dimension having an unstressed arched configuration whenplaced in the coronary sinus. The device partially encircles and exertsan inward pressure on the mitral valve. The inward pressure constrictsthe mitral valve annulus, or at least a portion of it, to essentiallyrestore the mitral valve geometry. This promotes effective valve sealingaction and eliminates mitral regurgitation.

[0011] The device may be implanted in the coronary sinus using onlypercutaneous techniques similar to the techniques used to implantcardiac leads such as pacemaker leads. One proposed system forimplanting the device includes an elongated introducer configured forbeing releasably coupled to the device. The introducer is preferablyflexible to permit it to advance the device into the heart and into thecoronary sinus through the coronary sinus ostium. To promote guidance,an elongated sheath is first advanced into the coronary sinus. Then, thedevice and introducer are moved through a lumen of the sheath until thedevice is in position within the coronary sinus. Because the device isformed of resilient material, it conforms to the curvatures of the lumenas it is advanced through the sheath. The sheath is then partiallyretracted to permit the device to assume its unstressed archedconfiguration. Once the device is properly positioned, the introducer isthen decoupled from the device and retracted through the sheath. Theprocedure is then completed by the retraction of the sheath. As aresult, the device is left within the coronary sinus to exert the inwardpressure on the mitral valve to restore mitral valve geometry.

[0012] The foregoing therapy has many advantages over the traditionalopen heart surgery approach. Since the device, system and method may beemployed in a comparatively noninvasive procedure, mitral valveregurgitation may be treated at an early stage in the mitralregurgitation progression. Further, the device may be placed withrelative ease by any minimally invasive cardiologist. Still further,since the heart remains completely intact throughout the procedure, theeffectiveness of the procedure may be readily determined. Moreover,should adjustments be deemed desirable, such adjustments may be madeduring the procedure and before the patient is sent to recovery.

[0013] Another approach to treat mitral regurgitation with a device inthe coronary sinus is based upon the observation that the application ofa localized force against a discrete portion of the mitral valve annuluscan terminate mitral regurgitation. This suggests that mitral valvedilation may be localized and nonuniform. Hence, the device applies aforce to one or more discrete portions of the atrial wall of thecoronary sinus to provide localized mitral valve annulus reshapinginstead of generalized reshaping of the mitral valve annulus. Suchlocalized therapy would have all the benefits of the generalizedtherapy. In addition, a localized therapy device may be easier toimplant and adjust. The present invention provides a still furtheralternative for treating mitral regurgitation with a device placed inthe coronary sinus adjacent to the mitral valve annulus.

SUMMARY OF THE INVENTION

[0014] The present invention provides a device for effecting mitralvalve annulus geometry of a heart. The device includes a first anchorconfigured to be positioned within and fixed to the coronary sinus ofthe heart adjacent the mitral valve annulus within the heart, a cablefixed to the first anchor and extending proximally from the first anchorwithin the heart, a second anchor configured to be positioned in andfixed in the heart proximal to the first anchor and arranged toslidingly receive the cable, and a lock that locks the cable on thesecond anchor. As a result, when the first and second anchors are fixedwithin the heart, the cable is drawn proximally, and the cable is lockedon the second anchor, the geometry of the mitral valve is effected.

[0015] The second anchor may be configured to be positioned and fixed inthe coronary sinus. Alternatively, the second anchor may be configuredto be positioned and fixed in the right atrium.

[0016] The first anchor may be self-expanding to fix the first anchor inthe coronary sinus. Similarly, the second anchor may be self-expandingto fix the second anchor in the heart.

[0017] The second anchor may include the lock. The lock may include aratchet. Further, the cable may include a coupling configured forreleasable connection to a cable tension assembly.

[0018] The present invention further provides a device for effectingmitral valve annulus geometry in a heart including first anchor meansfor anchoring within the coronary sinus of the heart adjacent to themitral valve annulus and second anchor means for anchoring within theheart proximal to the first anchor means. The device further includescable means fixed to the first anchor means and extending proximallyfrom the first anchor means, the cable means being slidably received bythe second anchor means for spanning between the first and second anchormeans, and lock means for locking the second anchor means to the cablemeans.

[0019] The present invention still further provides a method ofeffecting mitral valve annulus geometry in a heart. The method includesthe steps of fixing a first anchor within the coronary sinus of theheart adjacent to the mitral valve annulus, anchoring a second anchorwithin the heart proximal to the first anchor, fixing a cable to thefirst anchor, the cable extending proximally from the first anchor andslidably through the second anchor, displacing the cable proximallyrelative to the second anchor to create tension in the cable, andlocking the second anchor to the cable.

[0020] The present invention still further provides a system foreffecting mitral valve annulus geometry. The system includes a mitralvalve annulus device comprising a first anchor configured to bepositioned within and fixed to the coronary sinus of the heart adjacentto mitral valve annulus within the heart, a cable fixed to the firstanchor and extending proximally from the first anchor within the heart,a second anchor configured to be positioned and fixed in the heartproximal to the first anchor and arranged to slidingly receive thecable, and a lock that locks the cable on the second anchor. The systemfurther includes a delivery assembly that deploys the mitral valveannulus device, the delivery assembly including a first push tool thatengages the first anchor to position the first anchor within thecoronary sinus, a second push tool that engages the second anchor toposition the second anchor in the heart, and a tensioning memberconnectable to the cable that provides tension to the cable between thefirst and second anchors.

[0021] The present invention still further provides a method ofeffecting mitral valve geometry of a heart including the steps ofadvancing a guide catheter into the coronary sinus of the heart adjacentto the mitral valve annulus, pushing a self-deploying first anchor downand out of the guide catheter to deploy the first anchor in the coronarysinus adjacent to the mitral valve annulus, providing the first anchorwith a cable extending proximally from the first anchor and through asecond self-deploying anchor, and displacing the second self-deployinganchor down the guide catheter to a position proximal to the firstanchor. The method further includes the steps of withdrawing the guidecatheter while holding the second anchor to deploy the second anchor,pulling on the cable to create tension in the cable, and locking thecable to the second anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further aspects and advantages thereof, maybest be understood by making reference to the following descriptiontaken in conjunction with the accompanying drawings, and the severalfigures of which like reference numerals identify identical elements,and wherein:

[0023]FIG. 1 is a superior view of a human heart with the atria removed;

[0024]FIG. 2 is a superior view of a human heart similar to FIG. 1illustrating a deployed mitral valve device embodying the presentinvention;

[0025]FIG. 3 is a superior view of a human heart similar to FIG. 2illustrating an intermediate step in the deployment of the mitral valvedevice of FIG. 2 embodying the present invention;

[0026]FIG. 4 is a perspective view with portions cut away of the deviceof FIG. 2 and a delivery assembly for deploying the device in accordancewith an embodiment of the present invention;

[0027]FIG. 5 is a perspective view illustrating details of the couplingand locking mechanisms employed in the device and assembly of FIGS. 3and 4; and

[0028]FIG. 6 is a further superior view of a human heart similar to thatof FIG. 1 illustrating a further mitral valve device embodying thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

[0029] Referring now to FIG. 1, it is a superior view of a human heart10 with the atria removed to expose the mitral valve 12, the coronarysinus 14, the coronary artery 15, and the circumflex artery 17 of theheart 10 to lend a better understanding of the present invention. Alsogenerally shown in FIG. 1 are the pulmonary valve 22, the aortic valve24, and the tricuspid valve 26 of the heart 10.

[0030] The mitral valve 12 includes an anterior cusp 16, a posteriorcusp 18 and an annulus 20. The annulus encircles the cusps 16 and 18 andmaintains their spacing to provide a complete closure during a leftventricular contraction. As is well known, the coronary sinus 14partially encircles the mitral valve 12 adjacent to the mitral valveannulus 20. As is also known, the coronary sinus is part of the venussystem of the heart and extends along the AV groove between the leftatrium and the left ventricle. This places the coronary sinusessentially within the same plane as the mitral valve annulus making thecoronary sinus available for placement of the mitral valve therapydevice of the present invention therein.

[0031]FIG. 2 shows a mitral valve therapy device 30 embodying thepresent invention. As may be noted in FIG. 2, the device 30 includes afirst anchor 32, a cable 34, and a second anchor 36.

[0032] The first anchor 32 is located at the distal end of the device30. The anchor 32 is self-expanding so as to be self-deployable whenreleased in the coronary sinus 14. More specifically, the anchor 32 maybe formed of a material such as Nitinol, a nickel/titanium alloy of thetype well known in the art having shape memory. The anchor 32 has atoggle bolt-like configuration which expands when released to engage theinner wall of the coronary sinus 14 for anchoring or fixing the anchor32 therein. Preferably, the anchor 32 is positioned just proximally tothe crossover point 19 of the coronary sinus 14 and a circumflex artery17.

[0033] The cable 34, which may be a single wire, a multi-stranded wire,a polymer cable or a Nitinol cable, is fixed to the first anchor 32 andextends proximally therefrom. The cable extends through the secondanchor 36 which is positioned proximally from the first anchor 32. Hereit will be noted that the second anchor is positioned within thecoronary sinus just distal to the ostium 21 of the coronary sinus 14.The second anchor 36 may have a similar toggle bolt-like configurationand is also preferably self-expanding to be self-deployable.

[0034] The cable 34 terminates in a coupling 38. As may best be seen inFIG. 5, the coupling 38 is configured to releasably interlock with acorresponding coupling 40 carried by a tension cable 42.

[0035] As may further be noted in FIG. 5, the second or proximal anchor36 also includes a locking mechanism 44. Here, the locking mechanism 44takes the form of a ratchet or ratchet-like mechanism 46 for locking thesecond anchor 36 to the cable 32.

[0036] When the device 30 is deployed as shown in FIG. 2, the firstanchor 32 is fixed within the coronary sinus 14. The cable 34 extendsproximally from the anchor 32 and slidably through the second anchor 36.The second anchor 36 is then positioned in its desired location withinthe heart proximal to the first anchor 32 and permitted to self-expandfor being anchored within the heart. Then, the tension cable is used topull proximally on the cable while the second anchor 36 is preferablyheld in its fixed position. Once a desired amount of tension is appliedto the cable, the ratchet positively and permanently locks the cable 34to the second anchor 36. With the cable 34 now under tension, thegeometry of the mitral valve annulus 20 is now advantageously effected.The tension in the cable may be further adjusted while monitoring aparameter indicative of mitral regurgitation such as Doppler echo whileadjusting the tension. The tension may be further adjusted by pushingthe deployed proximal anchor 36 further down the cable 34 therebyshortening the distance between the proximal and the distal anchors.Once the proximal anchor position and proper cable tension is achieved,the tension cable assembly may be removed in a manner as more fullydescribed hereinafter.

[0037] As will further be noted in FIG. 2, the cable 34 is provided witha covering 33. The covering 33 is preferably formed of a compressiblematerial and serves to distribute forces of the cable applied againstthe inner wall of the coronary sinus 14. This force distributionprecludes damage to the coronary sinus by the cable 34.

[0038]FIGS. 3 and 4 show further details of the device 30 and itsdeployment assembly 50. As will be noted in FIG. 4, the deploymentassembly 50 includes a catheter 52. The catheter 52 has a lumen 54dimensioned for slidably receiving the device 30 in its predeployedstate. The catheter 52 is advanced into the coronary sinus until itsdistal end 56 is at a desired position within the coronary sinus.

[0039] The assembly 50 further includes a first push tube 58 whichengages a collar 33 of the first anchor 32. The push tube 58 may then beused to push the first anchor 32 to its desired position and out of thecatheter 52 whereupon, the first anchor 32 self-expands for deployment.Once the first anchor 32 is fixed within the coronary sinus, the pushtube 58 may then be removed.

[0040] The assembly 50 further includes a second push tube 60 coaxiallyarranged with the catheter 52 and first push tube 58 which may be feddown the catheter to engage the second anchor 36. The second push tube60 is then used to push the second anchor 36 along the cable 34 to itsdesired position. Then, the catheter 52 is retracted to release thesecond anchor 36 to permit it to self-expand and be deployed.

[0041] The tension cable 42 is then coupled to the coupling 38 of thecable 34 and covered with a sheath 62 to maintain the coupling of thecouplings 38 and 40. Tension is then applied to the cable 34 byproximally pulling on the tension cable 42 while the second push tube 60holds the second anchor 36 stationary. When the desired tension isplaced on the cable 34, further adjustment may be made as previouslydescribed. When this is completed, the first anchor 32 and the secondanchor 36 are fixed in position with a tension in the cable 34. Thecatheter 52, the sheath 62, the second push tube 60, and the tensioncable 42 may be removed to complete the deployment process.

[0042]FIG. 6 shows another mitral valve device 70 embodying the presentinvention. The device 70 is similar to the device 30 previouslydescribed except that its second or proximal anchor 76 is located andfixed within the right atrium 23 of the heart 10. To this end, thedevice 70 includes a first anchor 32, a cable 34, and a forcedistributor 33 as previously described. The second anchor 76 isconfigured so that when it self-expands, it engages the inner wall 25 ofthe right atrium 23 to hold it in place. In all other respects, thedevice 70 may be identical to the device 30.

[0043] While particular embodiments of the present invention have beenshown and described, modifications may be made, and it is thereforeintended in the appended claims to cover all such changes andmodifications which fall within the true spirit and scope of theinvention as defined by the appended claims.

1.-43. (Canceled)
 44. An assembly for effecting the condition of amitral valve annulus of a heart comprising: a mitral valve therapydevice that reshapes the mitral valve annulus of the heart when placedwithin the coronary sinus of the heart adjacent the mitral valveannulus, the mitral valve therapy device having a proximal end includinga coupling structure; a catheter having a lumen that directs the mitralvalve therapy device into the coronary sinus of the heart; a secondcoupling structure that is lockable on the device coupling structure;and a locking member that locks the device coupling structure to thesecond coupling structure and that releases the device couplingstructure from the second coupling structure.
 45. The assembly of claim44 further including a pusher member that pushes the device through thecatheter lumen, the pusher member having a distal end that engages thedevice proximal end.
 46. The assembly of claim 45 wherein the pushermember carries the second coupling structure at the distal end of thepusher member.
 47. The assembly of claim 44 wherein the device couplingstructure and the second coupling structure comprise a pair ofinterlocking structures and wherein the locking member comprises aslide-lock sheath closely fitted to the interlocking structures.
 48. Theassembly of claim 47 wherein the interlocking structures are formed fromtubing and wherein the slide-lock sheath is tubular.
 49. An assembly foreffecting the condition of a mitral valve annulus of a heart comprising:device means for reshaping the mitral valve annulus of the heart whenplaced within the coronary sinus of the heart adjacent the mitral valveannulus, the device means having a proximal end including a couplingmeans for coupling the device means; catheter means having a lumen thatdirects the mitral valve therapy device into the coronary sinus of theheart; second coupling means for locking with the device coupling means;and locking means for locking the device coupling means to the secondcoupling means and releasing the device coupling means from the secondcoupling means.
 50. The assembly of claim 49 further comprising a pushermeans for pushing the device means through the catheter means lumen, thepusher means having a lumen, and wherein the second coupling means andthe locking means extend through the pusher means lumen.
 51. Theassembly of claim 49 wherein the device coupling means and the secondcoupling means comprise interlocking means for releasably locking thedevice coupling means and the second coupling means, and wherein thelocking means includes retaining means for retaining the interlockingmeans in an interlocked condition.
 52. The assembly of claim 51 whereinthe retaining means is displaceable for releasing the interlockedcondition of the interlocking means.
 53. An assembly for effecting thecondition of a mitral 30 valve annulus of a heart comprising: a mitralvalve therapy device that reshapes the mitral valve annulus of the heartwhen placed within the coronary sinus of the heart adjacent the mitralvalve annulus, the mitral valve therapy device having a proximal endincluding a coupling structure; a guide member that directs the mitralvalve therapy device into the coronary sinus of the heart; a secondcoupling structure that is lockable on the device coupling structure;and a locking member that locks the device coupling structure to thesecond coupling structure and that releases the device couplingstructure from the second coupling structure.
 54. An assembly foreffecting the condition of a mitral valve annulus of a heart comprising:device means for reshaping the mitral valve annulus of the heart whenplaced within the coronary sinus of the heart adjacent the mitral valveannulus, the device means having a proximal end including a couplingmeans for coupling the device means; guide means for directing themitral valve therapy device into the coronary sinus of the heart; secondcoupling means for locking with the device coupling means; and lockingmeans for locking the device coupling means to the second coupling meansand releasing the device coupling means from the second coupling means.